Fujifilm starts a Phase I clinical trial in the United States for the anti-cancer agent “FF-10502” targeting solid tumors including pancreatic cancer

18.02.2016

FUJIFILM Corporation (President: Shigehiro Nakajima) has begun a Phase I clinical trial of its anti-cancer agent FF-10502 in the United States on patients with solid tumors, including pancreatic cancer. The trial will be expanded in facilities including at the University of Texas MD Anderson Cancer Center*, one of the world's most distinguished facilities for cancer research and treatment.

Pancreatic cancer is one of the difficult gastrointestinal cancers to treat, with limited choices of drugs and poor prognosis. The number of the patients developing pancreatic cancer is estimated to be approximately 50,000 and 35,000 per year in the United States and in Japan, respectively.

FF-10502 possesses anti-cancer effects by inhibiting DNA synthesis of the cancer cells. The effectiveness of FF-10502 includes regression of tumor tissues superior to a currently available drug, in pre-clinical mouse models of pancreatic cancer without significant difference in the safety profile from the existing drug. It has also shown potent anti-cancer effects in growth inhibition of cancer cells derived from patients with lung, ovarian and bladder cancers. FF-10502 required a long process in its chemical synthesis due to the unique structure, which resulted in difficulty in the development. Fujifilm has applied its advanced technologies in the chemical design and synthesis to improve the process and achieved lower costs.

MD Anderson Cancer Center is one of the world's top general cancer centers with over 10,000 patients on therapeutic clinical trials each year, and some 20,000 employees. Fujifilm is utilizing the world's top-level clinical testing functions available at the MD Anderson Cancer Center to speedily and seamlessly carry out Phase I clinical trials of FF-10502, to gain its safety profile and efficacies, and facilitates the development for early approval.

Fujifilm is defining oncology as its focal area and promoting the R&D of new drugs. Fujifilm has initiated clinical trials of anti-cancer agents FF-10501 for the treatment of relapsed or refractory blood tumors since August 2014, and FF-21101 for solid tumors such as lung cancer since January 2016 also at MD Anderson Cancer Center. The emerging results have revealed that to date FF-10501 has been well tolerated in those patients and produced positive responses in some patients. These results were presented last December at the 57th American Society of Hematology Meeting (Orlando, Florida), the biggest hematology meeting in the US.

Fujifilm is working on the R&D of innovative pharmaceutical products and creation of their production processes by combining the technologies and knowledge accumulated in the photographic film business including analysis technology, chemical design and synthesis technology, nanotechnology, and production technology, with the technological expertise of its core pharmaceutical affiliates such as Toyama Chemical Co., Ltd. Defining “oncology,” a field with numerous unmet medical needs as its focus, the company will actively promote R&D to expand business deployment and supply innovative pharmaceutical products to contribute to resolving challenging social and health issues.

*One of the world's largest cancer centers based in Houston, Texas (USA), specializing in cancer treatment, research, education and prevention. It was established in 1941 with a mission to eliminate cancer. Under the core values of “Caring,” “Integrity,” and “Discovery,” the center has developed numerous new cancer treatments as an international leader in oncology.